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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K210923
Device Name Southern Implants Instrument Trays
Applicant
Southern Implants (Pty), Ltd.
1 Albert Rd.
Guateng,  ZA 0062
Applicant Contact Lauranda G Breytenbach
Correspondent
Southern Implants (Pty), Ltd.
1 Albert Rd.
Guateng,  ZA 0062
Correspondent Contact Leith Cumming
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/29/2021
Decision Date 03/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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